BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 44ODX38ID

    MDR report key: 6889212 · Received September 24, 2017

    Report

    Report Number
    0001825034-2017-06923
    Event Type
    Injury
    Date Received
    September 24, 2017
    Date of Event
    December 8, 2014
    Report Date
    November 1, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: PART:11-173662 NAME: M2A 38MM MOD HD STD NK LOT: 942730. THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGAITON IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILE FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-03957.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INTIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 5 YEARS POST-IMPLANTATION DUE TO PAIN, DISCOMFORT, AND LACK OF MOBILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 5 YEARS POST-IMPLANTATION DUE TO PAIN, DISCOMFORT, LACK OF MOBILITY, TISSUE AND BONE DESTRUCTION, METAL WEAR, AND METAL POISONING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669026 M2A-MAGNUM PF CUP 44ODX38ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 269730

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R